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US 11,925,706 B2Granted
Manufacturing of bupivacaine multivesicular liposomes
AssigneePacira Pharmaceuticals, Inc.
InventorsJeffrey S. Hall, David J. Turnbull, John J. Grigsby, Jr., Soroush M. Ardekani, Kathleen D. A. Los
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Abstract
Embodiments of the present application relate to batches of bupivacaine multivesicular liposomes (MVLs) prepared by a commercial manufacturing process using independently operating dual tangential flow filtration modules.
Claims29
A composition of bupivacaine encapsulated multivesicular liposomes (MVLs), comprising:
- bupivacaine encapsulated MVLs comprising bupivacaine residing inside a plurality of internal aqueous chambers of MVLs separated by lipid membranes, wherein the lipid membranes comprise 1, 2-dierucoylphosphatidylcholine (DEPC), 1, 2-dipalmitoyl-sn-glycero-3-phospho-rac-(1-glycerol) (DPPG), cholesterol, and at least one neutral lipid, the plurality of internal aqueous chambers of the MVLs also comprise lysine;
- and
- an aqueous medium in which the bupivacaine encapsulated MVLs are suspended, wherein the aqueous medium also comprises unencapsulated bupivacaine;
- wherein the bupivacaine concentration in the composition is from about 11.3 mg/mL to about 17.0 mg/mL;
- wherein an erucic acid concentration in the composition is about 53 μg/mL or less when measured after the composition is stored at 25° C. for three months, and the erucic acid concentration in the composition is about 99 μg/mL or less when measured after the composition is stored at 25° C. for six months;
- and
- wherein the encapsulated lysine concentration in the composition is at least about 0.03 mg/mL.
4 more elements
Dependencies are inferred from the claim text.